Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention (IMA-cRCT)

Fundació Sant Joan de Déu

Status: Active, not recruiting

Conditions: Adherence, Medication

Treatments: Other: Usual care; Behavioral: Initial Medication Adherence (IMA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05026775

948973

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.

Full description

A pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the IMA intervention in comparison to usual care, in the increase of initiation of medicines for CVD and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in Primary Care (PC). The impact of the IMA intervention on secondary adherence and clinical indicators will be evaluated.

A multicenter pragmatic RCT, with cluster allocation and 2 parallel branches (IMA intervention vs. usual care) based on health records or RWD will be conducted.

PC centres' personnel, including general practitioners (GP), nurses and community pharmacists, from different areas around Catalonia (Spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of PC centre, either rural or urban and taking into consideration the size and localization of the PC centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the PC centre).

The IMA intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. PC centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the IMA website.

Enrollment: 4,153 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Primary Care health professionals and pharmacists who:
• Agree to participate in the clinical trial and process evaluation.
• Attend the training course
• Are not plannig to be on sick leave during the study period (e.g. maternity leave).
• Patients who:
• Are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial.
• Are >18 years old
• Do not reject to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,153 participants in 2 patient groups

Initial Medication Adherence (IMA) intervention

Experimental group

Description:

General practitioners (GP) will apply the IMA intervention to all patients receiving a new prescription for treatment of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists will offer information support in line with the information provided by the GP.

Treatment:

Behavioral: Initial Medication Adherence (IMA)

Usual care

Active Comparator group

Description:

Patients will receive the usual care when being prescribed a new prescription for treatment of cardiovascular disease or diabetes. Nurses and community pharmacists will be asked to also provide usual care to those patients.

Treatment:

Other: Usual care